RecruitingPhase 2NCT04348747

Dendritic Cell Vaccines Against Her2/Her3 and Pembrolizumab for the Treatment of Brain Metastasis From Triple Negative Breast Cancer or HER2+ Breast Cancer

A Phase IIa Study of Dendritic Cell Vaccines Against Her2/Her3 and Pembrolizumab in Patients With Asymptomatic Brain Metastasis From Triple Negative Breast Cancer (TNBC) or HER2+ Breast Cancer (HER2+BC) or Hormone Receptor Positive (HR+) Breast Cancer.


Sponsor

Roswell Park Cancer Institute

Enrollment

23 participants

Start Date

Dec 19, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This phase IIa trial studies how well dendritic cell vaccines against Her2/Her3 and pembrolizumab work for the treatment of triple negative breast cancer or HER2+ breast cancer or HER+ Breast cancer that has spread to the brain (brain metastasis). Dendritic cell vaccines work by boosting the immune system (a system in the body that protect against infection) to recognize and destroy the cancer cells. . Pembrolizumab is an "immune checkpoint inhibitor" which is designed to either "unleash" or "enhance" the cancer immune responses that already exist by either blocking inhibitory molecules" or by activating stimulatory molecules. Giving dendritic cell vaccines and pembrolizumab may shrink the cancer.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a personalized vaccine combined with an immunotherapy drug (pembrolizumab) for women with breast cancer that has spread to the brain. The vaccine is made from the patient's own immune cells (dendritic cells) and is designed to train the immune system to recognize and attack cancer cells that carry HER2 or HER3 proteins. **You may be eligible if:** - You are a woman with breast cancer — either triple-negative breast cancer or HER2-positive breast cancer — that has spread to the brain - You are not pregnant, not breastfeeding, and willing to use effective birth control throughout the study (which may be several years) - You meet additional health requirements your doctor will review **You may NOT be eligible if:** - You are pregnant or breastfeeding - You are unwilling to use contraception during the study period - You do not meet specific health and disease criteria your doctor will assess Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAnti-HER2/HER3 Dendritic Cell Vaccine

Given ID

BIOLOGICALPembrolizumab

Given IV


Locations(3)

Moffitt Cancer Center

Tampa, Florida, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

University of Virginia Comprehensive Cancer Center

Charlottesville, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT04348747


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